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Diarrhea clinical trials

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NCT ID: NCT03602053 Completed - Diarrhea Clinical Trials

Study of BBIL's ROTAVAC® and ROTAVAC 5CM Vaccines in Zambia

ROTAVAC
Start date: January 22, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

The study is being conducted to evaluate and compare the immunogenicity of ROTAVAC® and ROTAVAC 5D 28 days after the last dose of the vaccine, when administered to infants in a three-dose schedule at 6, 10 and 14 weeks of age. The study will also assess the reactogenicity of the vaccine 7 days after each vaccination and safety from first vaccination up to 4 weeks after the last vaccination with ROTAVAC® and ROTAVAC 5D, and of Rotarix® when administered to infants in a two-dose schedule at 6 and 10 weeks of age.

NCT ID: NCT03598010 Not yet recruiting - Diarrhea Clinical Trials

Safety, Tolerability and Preliminary Efficacy of Lenodiar Pediatric in Diarrhea

Start date: October 2019
Phase: N/A
Study type: Interventional

Evaluation of the efficacy of a treatment with Actitan-F, a natural molecular complex of tannins (from Agrimony and Tormentil) and flavonoids (Chamomile) in a pediatric population of children affected by acture/prolonged/chronic diarrhea

NCT ID: NCT03596827 Completed - Diarrhea Clinical Trials

The Protective Immune Response to Attenuated Enterotoxigenic Escherichia Coli Infection

MIRRE
Start date: September 26, 2018
Phase: N/A
Study type: Interventional

The existing diarrhoeagenic Escherichia coli (E. coli) challenge model is already suitable for dietary interventions in its current form, targeted to impact on the immediate clinical symptoms upon E. coli infection. In order to make the model also suitable for dietary interventions that are aimed at support of the protective response against reinfection, the immune response triggered by the primary infection should be suboptimal. The MIRRE pilot study is set up to determine how much the primary inoculation dose of diarrheagenic E. coli should be lowered in order to result in a reduced protective response upon a secondary infection.

NCT ID: NCT03594279 Completed - Childhood Pneumonia Clinical Trials

Community Mobilization and Incentivization for Childhood Diarrhea and Pneumonia

CoMIC
Start date: July 1, 2017
Phase: N/A
Study type: Interventional

Childhood diarrhea and pneumonia remains the leading cause of mortality among children under five years of age in Pakistan. The prevalence of diarrhea in Pakistan has increased from 15% in 1990 to 23% in 2013 while there has been no progress in the prevalence of pneumonia and it has been almost constant over the last two decades. The coverage of preventive and therapeutic interventions for childhood diarrhea and pneumonia also remains low. This study aims to improve the adherence to recommended preventive and curative practices for childhood diarrhea and pneumonia.

NCT ID: NCT03587389 Completed - Diarrhea Clinical Trials

Response to Rotavirus Vaccine in Infants in Ho Chi Minh City in Vietnam

Start date: March 19, 2019
Phase: Phase 4
Study type: Interventional

The primary objective is to measure the effect of host human genetics on the resulting immunological responses and long-term protection following rotavirus immunization of a study population of infants in Ho Chi Minh City, Vietnam. The secondary objectives are to assess the temporal immunological responses following rotavirus vaccination, and to investigate the role of maternally derived antibodies, and other factors that could potentially affect immunological responses following rotavirus vaccination. Also to assess infecting rotavirus genotypes in the vaccine failure cases.

NCT ID: NCT03576183 Completed - Diarrhea Clinical Trials

Study Confirming A Human Challenge Model and Investigating The Safety Of VLA1701

Start date: June 4, 2018
Phase: Phase 2
Study type: Interventional

This is a single-center, double-blind, placebo-controlled, Phase II vaccination and challenge study designed to confirm a human challenge model with E. coli strain LSN03-016011/A.

NCT ID: NCT03565393 Completed - Diarrhea Clinical Trials

Tolerability and Acceptability of Fibersol-2 in Children

Start date: March 19, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Dietary fiber, a non-digestible carbohydrate, used in decades for the beneficial effect on health with physiological importance because such compounds have low energy values. These indigestible carbohydrates generally reach the large intestine undigested and unabsorbed, they are often used in many functional and/or low-calorie food and beverages. Researchers have stated that dietary fiber especially digestive-resistant maltodextrin has innumerable beneficial effects on human health, such as improving intestinal regularity by increasing fecal bulk, stimulating peristalsis and shortening gastrointestinal transit time. Resistant maltodextrin (Fibersol-2) is a low viscosity, water-soluble, indigestible dextrin produced by the treatment of corn starch with acid, enzymes, and heat. Dietary fiber, a non-digestible carbohydrate, has been used in decades for the beneficial effect of health with physiological importance. In developing countries most of the diarrhea episodes occur during the first two years of life and till date antibiotics have been found to have no role in over seventy five percent of young childhood diarrhea. Toddler's diarrhea which affects children aged 6 to 60 months is known as chronic nonspecific diarrhea of childhood. The stool is frequently watery or loose and may have food particles in it. Despite the diarrhea, the child continues to grow and gain weight, remains active and has a normal appetite. The beneficial effects of resistant maltodextrin are well known in developed countries; however, data are lacking in developing countries. It has become imperative to know its safety, tolerability and acceptability in small children with or without diarrhea in developing countries such as in Bangladesh.

NCT ID: NCT03557788 Completed - Clinical trials for Irritable Bowel Syndrome With Diarrhea

Changes in Microbiota and Metabolomic Profile Between Rifaximin Responders and Non-responders In Diarrhoea-Predominant Irritable Bowel Syndrome

Start date: May 7, 2018
Phase: Phase 4
Study type: Interventional

Irritable Bowel Syndrome (IBS) carries a high prevalence worldwide and imposes substantial economic burden on patients, healthcare systems and society. In recent years, dysbiosis of the gut microbiota and bile acid (BA) malabsorption have been identified as putative pathophysiological mechanisms. Bile acid metabolism and gut microbiota are closely related. When patients with IBS-D were compared to healthy subjects, total levels of faecal BAs do not differ, but increased faecal primary BAs and reduced secondary BAs have been repeatedly observed in patients with IBS-D, suggesting abnormal BA deconjugation. Rifaximin, a non-absorbable antibiotic, has been shown in a recent meta-analysis to produce a therapeutic clinical gain compared to other treatment options for IBS, including placebo, paralleled by a high safety profile. It is also now known that changes in fecal microbiota have been observed in patients with IBS who have responded positively to Rifaximin. The relationship between microbiota changes, metabolomics changes after Rifaximin is unclear. There is emerging data to suggest duodenal dysbiosis as a putative pathophysiology, which in one study, clustered together with salivary microbiota than with fecal microbiota. However, the oral microbiome in patients with IBS has never been explored, which could possibly explain the downstream observations of duodenal and fecal dysbiosis. The investigators aim to assess the changes in metabolomic and microbiota profile after Rifaximin treatment, between responders and non-responders. The investigators will also explore the oral microbiome in IBS patients, and assess its relationship with fecal microbiome between responders and non-responders.

NCT ID: NCT03555188 Completed - Clinical trials for IBS - Irritable Bowel Syndrome

TReatment of Irritable Bowel Syndrome With Diarrhoea Using Titrated ONdansetron Trial

TRITON
Start date: March 29, 2018
Phase: Phase 3
Study type: Interventional

A placebo controlled study to determine the efficacy and mode of action of ondansetron in the treatment of irritable bowel syndrome with diarrhoea.

NCT ID: NCT03536286 Completed - Diarrhea Clinical Trials

Asili Evaluation in the Democratic Republic of Congo

Start date: August 4, 2016
Phase: N/A
Study type: Interventional

The South Kivu province of DRC has experience continuous armed conflict over the last several decades; as a result, livelihoods and health metrics are uniformly poor. Thus, the objective of this study is to determine if an integrated set of social enterprises can improve child health while offering viable and scalable new business opportunities for the community. Specific research questions include the impact of the individual enterprises on (1) child health, (2) access to clean water, and (3) economic opportunities in the region.